This Sounds Like A Class-Action Suit In The Making

Scientists have won FDA approval for a birth-control pill that halts the menstrual cycle altogether. The Washington Post reports that Lybrel will halt periods in 60% of women who take it daily, but some women’s health advocates warn that the research did not go far enough into the effects that will have:

The Food and Drug Administration yesterday approved the first birth control pill that eliminates a woman’s monthly period.
Taken daily, the contraceptive, called Lybrel, continuously administers slightly lower doses of the same hormones in many standard birth control pills to suppress menstruation. It is designed for women who find their periods too painful, unpleasant or inconvenient and want to be free of them.
“This will be the first and only oral contraceptive designed to be taken 365 days a year, allowing women to put their periods on hold,” said Amy Marren of Wyeth Pharmaceuticals, which expects Lybrel to be available with a prescription by July. “There are a lot of women who think that’s a great option to have.” …
“There may be important health consequences that we don’t know about,” said Christine L. Hitchcock, an endocrinology researcher at the University of British Columbia. “I don’t think we understand everything that the menstrual cycle does well enough to say with confidence that you can abolish it and not have any consequences.”

I have nothing against birth control. It should be available as an option for anyone who wants it. If women want to take a pill that will eliminate menstruation as well as ovulation, that’s their choice. In some cases, it will allow women who have terrible problems with menstruation to lead normal lives. I see no reason for the FDA to reject it — but they should take the time to discover what that means for women before approving its use, especially the long-term effect on the ability to conceive. From the description in the Post, it does not appear that depth of research has been performed.
This sounds like a class-action lawsuit just waiting for a few years and a couple of lawyers. Vioxx was supposed to be a wonder drug too, and the First Mate had taken Propulsid for a couple of years before its recall. Neither of those had the profound systemic effect described for Lybrel. If I’m still blogging in ten years, I’m going to bet that we will be discussing a massive settlement with millions of women as plaintiffs.

14 thoughts on “This Sounds Like A Class-Action Suit In The Making”

  1. Law suits have nothing to do with common sense.
    As to “class action” … you get pennies. But you fill out a lot of paper. And, the lawyers make bundles. Will this hold true, ahead?
    Perhaps, lawyers will finally hit the wall, here?
    As to the drug, there’s another bet. Buy the stock, and see what happens in ten years.
    WHile birth control pills, which became available way back in early 1970, did stop heavy flows. Women on pills for years would get ver “light days.” And, they’d be regular.
    And, anyone who bought Syntex, then, did well. But the drug company eventually bought out all the public holders. And, they went private.
    Still, the science, if you think about it, is phenomenal.
    And, this is just another product, now. Where once there wasn’t much even married couples could depend on.
    By the way, there are lots of medical miracles. Nothing is free of cost, though.
    The best advice? Women should talk to their doctors.
    As to taking pills every day; I don’t know the drop off rate. But its hard to get people to take antibiotics for the whole course, usually not longer than ten days.
    ANd, most doctors complain that patient compliance is poor.
    The other thing? Who will these women sue if they’re gonna buy their drugs at discount? By mail? From some foreign country? You think not? It’s $50 for 60 pills, or one month’s supply.
    I think if you checked people’s medicine cabinets you’d find an array of prescription meds that are in old vials. (Same thing if you check the spice cabinet. Do you know how hold some of that stuff is? According to Emeril, lots of women throw into their recipes things that have long passed their expiration dates.)
    People build better mouse traps because they want products that sell.
    Here? In a market that has lots of choices these days, scientists still worked it so they’d come up with a new “angle.”
    I can remember back when my mom talked about what it was like before Kotex. (She was born in 1905. She told me women used rags. Then she told me, women couldn’t be fitted for diaphrams, easily, either.) Yup. A time when we didn’t have access to products at the supermarket. And, some religious folks worked overtime, to keep people away from the birth control.
    Sometimes, ya wonder if amnesia hasn’t set in on what was so common half a century, ago.

  2. I don’t think Vioxx has been as much of a disaster for Merck as it could have been. I don’t think anyone has actually won a lawsuit against them yet. Sure they’re probably making a small army of lawyers very rich defending themselves, but that beats paying out so much money that they go bankrupt.
    As for Lybrel, I would bet that there are some long-term consequences for a minority of users of the drug. But the FDA procedures, at least to this layman, seem pretty onerous already. Requiring long-term (10 or more years) of clinical studies before a drug can go to market would hurt consumers and drug companies.

  3. Women have been taking regular birth control pills every day for years. I doubt compliance with this version will be any different.
    Women have also been taking active pills continously for months at a time for several years. You just take the three weeks of active pills, discard the seven placebos, and start a new pack immediately. Been there, done that. No big deal.
    With the current version of the Pill, I’m pretty sure that the ability to conceive after stopping the Pill is related to one’s ability to conceive before being on the Pill. That is, women who have no fertility problems before being on the Pill are not likely to have them after getting off. Women with fertility problems before going on the Pill are likely to have problems after getting off.

  4. Synthetic BC pills are dangerous, I’ve seen women die from them, and seen other women suffer severe liver damage, taking years of “AGENT ORANGE” style baths to recover them from the appearance of Poison Ivy style rashes carpetting their skin, head to toe, including scalp and palms of hands, soles of feet.
    Doctors haven’t learned to treat the average woman properly for hormone imbalances for Thyroid and female hormones YET, and every time we read the list of symptoms of women’s hormone imbalances, we know we aren’t as close to treating them correctly as American Indians of the 1600’s were.
    Now, for the convenience of even more promiscuous and irresponsible sex, they want to treat women as irresponsibly as they handle inflatable dolls.
    Sow to the wind…

  5. Rose, I’ve never heard of the extreme side-effects that you describe, but if you could provide a link I would be grateful.
    As for the pill promoting promiscuous and irresponsible sex, I think you’re ignoring the practical uses for people in monogamous relationships. I’m sure many married women (and I know a few) use birth control because they’re not ready to have a child. Sure there are other contraceptive measures a married couple could take, but BC pills are definitely the easiest.

  6. I am more concerned with possible unknown consequences. It had been my understanding that the uterus needs a flushing out of aged lining to prevent disease and stagnation. Maybe that is not the case. Perhaps research has shown that menstruation is not necessary if one is not seeking conception. But I haven’t heard of such studies.
    I have no moral problems with birth control nor does it bother me that many women seek to live their lives without menstruation. There is just something about this that hasn’t been thought through.

  7. The Pill is useful even for women who aren’t having sex at all. I was on the Pill for most of my adult reproductive life and it did not make me fall into bed with every Tom, Dick, or Harry who came along.
    I was on the Pill even when there was absolutely NO chance of me getting pregnant (can’t get pregnant when you’re not having sex). I had a choice a seven or eight day period, with three or four days of flooding, or three days of a spot here and a spot there, hardly even being aware that I was having a period. I could have no control over when I had my period, or I could know exactly when it would start and time it so that the three days were always in the middle of the week, not interfering with my weekends. What do you think I chose???
    I even when back on the Pill AFTER I had my tubes tied because of those miserable periods.
    Doctors used to believe that you needed a break from the Pill, so you’d have to go off a month or two every once in awhile, but they no longer believe that. They also no longer believe that you must have a regular period. The only reason for the placebo pills (and the resulting period) is to reassure a woman that she’s not pregnant.

  8. What a lot of rubbish, by both Ed and respondents. You have become a journalist, Ed. Soon you’ll be writing for the NYT.

  9. The pill, in general, prevents the uterine lining from building up. Therefore there’s no need to “flush.” One way or another, many doctors are still going to recommend giving your body a break every few months (or at least once a year) in case of minimal buildup – giving the body a chance to flush our dead tissue (this is why there’s breakthrough bleeding – it takes time to stop).
    I have a low estrogen level and don’t exactly have a cycle one way or the other, so I’ve always skipped the sugar pills at the end. And I can say that nothing bad has ever happened from *not* having my period, but that’s my experience, and each woman is different.
    Additionally, my understanding is that Lybrel has one of the lowest hormone levels out there, meaning that fertility will be “restored” shortly after a woman stops taking it (also less chance of blood clots and other side effects). I think the average time to become fertile again after being on birth control is a few months – this would probably be less. Again, though, it would depend on the woman and her fertility before going on the pill, as mentioned by others here.
    I really don’t think this is going to be much of an issue. Birth control pills today are safer than they ever have been. Lybrel is essentially the same thing as every other birth control pill. However, in today’s sue-happy culture….well, it remains to be seen.

  10. I love having my monthly period, cramps and all: it’s a monthly reminder of my glorious womanhood. There will come a time soon enough when I will be forced to live without it so for now I am appreciating having it for as long as I can.
    The problem I have with advocating women use The Pill is that it does nothing to prevent AIDS and other STDs which explains why according top the CDC the STDs rates for females 16 to 25 is almost epidemic. But hey who cares about that…as long as there’s an orgasm women are willing to contract STDs for which she’ll need to take several more pills to eleviate the symptoms of her many diseases.

  11. What is the effect on libido? I have read reports that the pill tends to reduce it, this would probably be worse.

  12. Sheesh! Some of y’all are just ridiculous! Everybody’s a critic, and hang personal responsibility.
    Only an idiot would think that she’s protected from STDs if she takes the Pill. I doubt that the Pill is soley responsible for the STD rate among young females. Plenty of those are getting pregnant, which isn’t the fault of the Pill. If you’re in a monogamous relationship with someone who is STD-free, this pill isn’t going to change the risk, which is ZERO.
    Why would this low-dose pill have a worse effect on libido than the regular pill? A lot of libido is mental. If you have a loving, caring, considerate partner, your libido’s likely to be higher than if you have a selfish, uncaring, inconsiderate one. Also, if you’re not worried about getting pregnant, it’s easier to relax and enjoy.
    The only people whose business this is are the woman, her doctor, and her partner (if she has one). It’s nobody else’s place to pass judgment, especially when you’re speculating about whether it leads to promiscuity, more STDs, lower libido, or whatever other horrible, terrible, awful things you want to protect some poor, innocent ADULT woman from.

  13. Hearing of this RX and others that reduce the menstrual cycle, my initial thought dealt with the long term effect, beyond conception, to what happens eventually to the female body without the normalcy of the hormone cycles. It seems to align with menopause, in which case, why jump from the frying pan into the fire?

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